recalcitrant plantar viral warts MedDRA version: 12.1 Level: LLT Classification code 10035158 Term: Plantar warts
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Recalcitrant plantar warts for more than 3 months Age over 18 years Fertile women must use safe contraceptive medicine/method Must be able to attend to study treatments Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Immunosuppression Pregnant or lactating women Previous Metvix treatment for the plantar warts Allergies towords the study IMPs Porphyria Patients who development of keloids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clearance rate of plantar warts at end of study compared to baseline;Secondary Objective: Pain associated with Metvix photodynamic therapy Adverse events ;Primary end point(s): Number of plantar warts at end of study compared to baseline Pain related to photodynamic therapy Number and severity of adverse events | — |
Countries
Denmark